Weight-bearing lower extremity brace

ABSTRACT

The present disclosure relates, according to some embodiments, to a device and/or system (e.g., redistributing weight away from a subject&#39;s foot), which may comprise (a) a platform, (b) at least one vertical support fixed to the platform and extending upwardly from the platform, and (c) at least one cuff (i) configured to surround and releasably grip at least a portion of a subject&#39;s leg other than the foot and (ii) mounted (e.g., adjustably) to the at least one vertical support at a vertical position along the at least one vertical support sufficient to suspend a subject&#39;s foot in a non-weight-bearing position above the platform during ambulation, wherein the platform, the at least one vertical support, and the at least one cuff together are configured to bear at least the subject&#39;s full weight.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. application Ser. No.12/502,893 filed Jul. 14, 2009, which itself is a continuation-in-partof U.S. application Ser. No. 12/404,104 filed Mar. 13, 2009, whichitself is a continuation-in-part of U.S. application Ser. No. 12/324,185filed Nov. 26, 2008, now issued as U.S. Pat. No. 8,021,316. Thisapplication also is a continuation-in-part of U.S. application Ser. No.12/684,573 filed Jan. 8, 2010, which itself is a continuation of PCTapplication No. US09/037171 filed Mar. 13, 2009, which itself is acontinuation-in-part of U.S. application Ser. No. 12/324,185 filed Nov.26, 2008, now issued as U.S. Pat. No. 8,021,316. The contents of all ofthe above are hereby incorporated in their entirety by reference.

FIELD OF THE DISCLOSURE

The present disclosure relates, according to some embodiments, tomethods, devices, and systems for ambulation of a subject having animpaired lower extremity.

BACKGROUND OF THE DISCLOSURE

Subjects unable to support their own weight due to a lower extremityimpairment may resort to crutches or wheel chairs to move about.However, crutches and wheel chairs may be undesirable because of thelimitations they impose on a subject's ability to use their hands. Inaddition, crutches and/or wheel chairs may incompletely restoremobility, and/or may be untenable in an older person due to decreasedupper body strength and/or poor balance in the case of crutches.

SUMMARY

Accordingly, a need has arisen for improved ambulatory devices forsubjects with impairments of the lower extremities. The presentdisclosure relates, according to some embodiments, to methods, devices,and systems for ambulation of a subject having an impaired lowerextremity. For example, a device may comprise a lower extremity braceconfigured to bear a subject's weight and/or transfer the load tounimpaired organs and/or tissues.

According to some embodiments, a device and/or system (e.g.,redistributing weight away from a subject's foot) may comprise (a) aplatform, (b) at least one vertical support fixed to the platform andextending upwardly from the platform, and (c) at least one cuff (i)configured to surround and releasably grip at least a portion of asubject's leg other than the foot and (ii) mounted (e.g., fixedly,adjustably) to the at least one vertical support at a vertical positionalong the at least one vertical support sufficient to suspend asubject's foot in a non-weight-bearing position above the platformduring ambulation, wherein the platform, the at least one verticalsupport, and the at least one cuff together are configured to bear atleast the subject's full weight. A vertical support may comprise, insome embodiments, a strut positioned relative to the subject's leg onwhich the system is worn opposite the subject's sagittal plane oropposite the subject's coronal plane. For example, a strut may bepositioned generally behind the subject's leg on which the system isworn. In some embodiments, a strut positioned generally behind thesubject's leg on which the system is worn may have an S-curve profile. Avertical support may comprise, for example, a strut configured to extendalong the outside of the leg on which the system is worn. In someembodiments, a vertical support may extend distal to the subject's foot(e.g., extend from about the tibial plateau to beyond the bottom of thesubject's foot). In some embodiments, a cuff may comprise an anteriorshell, an opposing posterior shell, and at least one tension adjustmentfastener configured to releasably connect the anterior shell and theposterior shell, wherein the anterior shell and the posterior shell areconfigured to combine to surround the circumference of the subject'sleg. In some embodiments, alignment or guide pins may be used to guidethe anterior and posterior shells into proper alignment and to providefurther support for the device when it is surrounding the circumferenceof the subject's leg. A cuff may comprise at least one collar (e.g.,adjustably mounted to the at least one vertical support), according tosome embodiments. A collar may have, in some embodiments, opposing endsspaced apart and a tension adjustment fastener corresponding to eachcollar, each tension adjustment fastener configured to releasablyconnect the opposing ends of the corresponding collar, wherein eachcollar and corresponding tension adjustment fastener are togetherconfigured to surround the circumference of the subject's leg.

According to some embodiments, a cuff may further comprise at least onepad shell fixed to the at least one collar, and at least one pad fixedto the at least one pad shell. A pad shell may comprise a moldableplastic selected from the group consisting of a thermoplastic, athermosetting plastic, and combinations thereof, in some embodiments. Apad may comprise, according to some embodiments, a material selectedfrom the group consisting of polyurethane, polyethylene, neoprene,ethylene vinyl acetate, foam, silicone, rubber, and combinationsthereof. In some embodiments, a cuff may include a second pad shellfixed to the at least one collar and a second pad fixed to the secondpad shell. A cuff including two pads and pad shells may be arranged suchthat the first pad comprises an anterior pad, the first pad shellcomprises an anterior pad shell, the second pad comprises a posteriorpad, and the second pad shell comprises a posterior pad shell, accordingto some embodiments. A cuff may be configured to extend from about thegastrocnemius/solius muscles to about the tibial plateau, according tosome embodiments. A device and/or system (e.g., for redistributingweight away from a subject's foot) may comprise, in some embodiments, anoutsole fixed to the platform and configured to contact the groundduring ambulation. In some embodiments, an outsole may comprise a flangeextending, for example, vertically along at least a portion of the backof the vertical support.

A shell (e.g., anterior shell), according to some embodiments, maycomprise at least one fastener guide positioned across the anteriorsurface of the anterior shell and configured to receive at least aportion of the at least one tension adjustment fastener. In someembodiments, a shell (e.g., anterior shell, posterior shell) maycomprise a moldable plastic selected from the group consisting of athermoplastic, a thermosetting plastic, and combinations thereof. Ashell (e.g., anterior shell, posterior shell) may be mounted (e.g.,fixedly, adjustably) to the at least one vertical support in someembodiments. A shell (e.g., anterior shell, posterior shell), accordingto some embodiments, may include an attached pad. For example, a cuffmay include one or more pads fixed to (e.g., lining) at least a portionof the surface(s) proximal to the subject's skin. Each cuff and/or eachshell may include a pad. Each pad may independently comprise a materialselected from the group consisting of polyurethane, polyethylene,neoprene, ethylene vinyl acetate, foam, silicone, rubber, andcombinations thereof. In some embodiments, a cuff may comprise one ormore bladders fixed to (e.g., lining) at least a portion of thesurface(s) proximal to the subject's skin. Each cuff and/or each shellmay include a bladder. Each bladder may be filled (e.g., at leastpartially filled, completely filled) with a fill material. A fillmaterial may comprise a foam. A fill material may provide, for example,a cushioned and/or custom fit.

According to some embodiments, a device and/or system (e.g., forredistributing weight away from a subject's foot) may be configured tosecure a subject's leg in a bent (e.g., slightly bent) position. Avertical support may comprise, for example, a vertical rod (e.g.,extending distal to the subject's foot). A lateral bar may be interposedbetween the at least one cuff and the vertical rod, in some embodiments.A device and/or system (e.g., for redistributing weight away from asubject's foot) may comprise, according to some embodiments, a secondcuff, the second cuff (a) configured to surround and releasably grip atleast a second portion of a subject's leg other than the foot and (b)mounted (e.g., fixedly, adjustably) to the at least one vertical supportat a vertical position along the at least one vertical supportsufficient to suspend a subject's foot in a non-weight-bearing positionabove the platform during ambulation.

In some embodiments, a device and/or system (e.g., for redistributingweight away from a subject's foot) may comprise further (d) a hingeattached to the upper end of the vertical support, (e) a second verticalsupport rotatably attached to the hinge, and (f) a second cuff, thesecond cuff (i) configured to surround and releasably grip at least asecond portion of a subject's leg other than the foot and (ii) mounted(e.g., fixedly, adjustably) to the second vertical support at a verticalposition along the second vertical support sufficient to cooperate withthe first cuff to suspend a subject's foot in a non-weight-bearingposition above the platform during ambulation. A second cuff may beconfigured to extend from about the proximal patella to about the upperquadriceps. According to some embodiments, a device and/or system (e.g.,for redistributing weight away from a subject's foot) may comprise amated shoe comprising a lift configured to vertically align thesuspended foot and the other foot. In some embodiments, a strut may beconfigured to be contiguous with its adjacent platform.

The present disclosure relates, in some embodiments, to methods forfacilitating ambulation of a subject having a leg with an impaired lowerextremity. A method may comprise, for example, suspending at least aportion of the impaired lower extremity in a non-weight bearing positionusing a load redistribution system and redistributing the weight to oneor more unimpaired regions of the leg using the load redistributionsystem. Redistributing the weight to one or more unimpaired regions ofthe leg may comprise, in some embodiments, redistributing the weight toone or more lateral surfaces (e.g., unimpaired lateral surfaces) of theleg. According to some embodiments, a method may comprise adjusting thepressure applied to at least one lateral surface (e.g., by substitutingwith a different contact surface area). A method (e.g., for facilitatingambulation of a subject having a leg with an impaired lower extremity)may comprise, for example, contacting the leg with a load redistributionsystem to suspend at least the impaired lower extremity in a non-weightbearing position and redistributing at least the weight of the subjectduring ambulation to one or more unimpaired regions of the leg. A loadredistribution system may include, in some embodiments, a platform, atleast one vertical support fixed to the platform and extending upwardlyfrom the platform, and at least one cuff mounted (e.g., fixedly,adjustably) to the at least one strut at a position sufficient tosuspend the at least a portion of the impaired lower extremity in anon-weight-bearing position above the platform during ambulation,wherein the platform, the at least one strut, and the at least one cuffare configured to (a) bear at least the subject's full weight and (b)distribute the weight born to at least a portion of the subject's legother than the subject's foot.

In some embodiments, a device and/or system (e.g., for redistributingweight away from a subject's foot) may comprise a means for suspending asubject's foot in a non-weight-bearing position and a means forredistributing a subject's weight to at least one surface on thesubject's leg.

According to some embodiments, a lower extremity brace may comprise anysuitable material, which may vary according each intended use and/oreach component of a brace. A lower extermity brace may comprise, forexample, a material selected from steel, a steel alloy, aluminum, analuminum alloy, titanium, a titanium alloy, carbon fiber, wood, anaramid fiber, a para-aramid fiber (e.g., KEVLAR), fiberglass, plastic(e.g., rigid, semi-regid, resilient, flexible, and/or moldable),flexible, elastomeric, and/or resilient materials (e.g., polyurethane,polyethylene, neoprene, ethylene vinyl acetate, foam, silicone, rubber,and the like), and combinations thereof.

A lower extremity brace may be configured to reduce or eliminate atuorniquet effect in some embodiments. For example, a lower extremitybrace may comprise a prosthetic suspension sleve (e.g., comprisingurethane and/or silicone) to provide circumferential compression, toprovide skin protection, to increase suspension, and/or to minimizecompression of the lower extremity.

BRIEF DESCRIPTION OF THE DRAWINGS

Some embodiments of the disclosure may be understood by referring, inpart, to the present disclosure and the accompanying drawings, wherein:

FIG. 1A illustrates a generally isometric view of a device forambulation of a subject having an impaired lower extremity according toa specific example embodiment of the disclosure;

FIG. 1B illustrates a left profile view of the device for ambulation ofa subject shown in FIGURE 1A according to a specific example embodimentof the disclosure;

FIG. 1C illustrates a right profile view of the device for ambulation ofa subject shown in FIG. 1A according to a specific example embodiment ofthe disclosure;

FIG. 1D illustrates a front view of the device for ambulation of asubject shown in FIG. 1A according to a specific example embodiment ofthe disclosure;

FIG. 2A illustrates a generally isometric view of a device forambulation of a subject having an impaired lower extremity according toa specific example embodiment of the disclosure;

FIG. 2B illustrates a generally isometric view of a device forambulation of a subject having an impaired lower extremity according toa specific example embodiment of the disclosure;

FIG. 3A illustrates a generally isometric view of a device forambulation of a subject having an impaired lower extremity according toa specific example embodiment of the disclosure;

FIG. 3B illustrates a left profile view of the device for ambulation ofa subject shown in FIG. 3A according to a specific example embodiment ofthe disclosure;

FIG. 3C illustrates a right profile view of the device for ambulation ofa subject shown in FIG. 3A according to a specific example embodiment ofthe disclosure;

FIG. 3D illustrates a front view of the device for ambulation of asubject shown in FIG. 3A according to a specific example embodiment ofthe disclosure;

FIG. 4 illustrates a profile view of a device for ambulation of asubject having an impaired lower extremity according to a specificexample embodiment of the disclosure;

FIG. 5A illustrates a front view of a device for ambulation of a subjecthaving an impaired lower extremity according to a specific exampleembodiment of the disclosure;

FIG. 5B illustrates a generally isometric view of a cuff according to aspecific example embodiment of the disclosure;

FIG. 6A illustrates a generally isometric view of a device forambulation of a subject having an impaired lower extremity according toa specific example embodiment of the disclosure;

FIG. 6B illustrates a generally isometric view of the device forambulation of a subject shown in FIG. 6A according to a specific exampleembodiment of the disclosure;

FIG. 6C illustrates a generally isometric view of the device forambulation of a subject shown in FIG. 6A according to a specific exampleembodiment of the disclosure;

FIG. 6D illustrates a generally isometric view of the device forambulation of a subject shown in FIG. 6A according to a specific exampleembodiment of the disclosure;

FIG. 6E illustrates a generally isometric view of the device forambulation of a subject shown in FIG. 6A according to a specific exampleembodiment of the disclosure;

FIG. 6F illustrates a right profile view of the device for ambulation ofa subject shown in FIG. 6A according to a specific example embodiment ofthe disclosure;

FIG. 6G illustrates a left profile view of the device for ambulation ofa subject shown in FIG. 6A according to a specific example embodiment ofthe disclosure;

FIG. 6H illustrates a rear view of the device for ambulation of asubject shown in FIG. 6A according to a specific example embodiment ofthe disclosure;

FIG. 7A illustrates a generally isometric view of a device forambulation of a subject having an impaired lower extremity according toa specific example embodiment of the disclosure;

FIG. 7B illustrates a generally isometric view of the device forambulation of a subject shown in FIG. 7A according to a specific exampleembodiment of the disclosure;

FIG. 7C illustrates a left profile view of the device for ambulation ofa subject shown in FIG. 7A according to a specific example embodiment ofthe disclosure;

FIG. 7D illustrates a left profile view of the device for ambulation ofa subject shown in FIG. 7A according to a specific example embodiment ofthe disclosure;

FIG. 7E illustrates a left profile view of the device for ambulation ofa subject shown in FIG. 7A according to a specific example embodiment ofthe disclosure;

FIG. 7F illustrates an exploded view of the device for ambulation of asubject shown in FIG. 7A according to a specific example embodiment ofthe disclosure;

FIG. 7G illustrates an exploded view of the device for ambulation of asubject shown in FIG. 7A according to a specific example embodiment ofthe disclosure;

FIG. 7H illustrates a generally isometric view of the device forambulation of a subject shown in FIG. 7A according to a specific exampleembodiment of the disclosure;

FIG. 8A illustrates a generally side view of a device for ambulation ofa subject having an impaired lower extremity according to a specificexample embodiment of the disclosure; and

FIG. 8B illustrates a generally isometric view of the device forambulation of a subject shown in FIG. 8A according to a specific exampleembodiment of the disclosure.

DETAILED DESCRIPTION

The present disclosure relates, according to some embodiments, tomethods, devices, and systems for facilitating ambulation (e.g.,walking, running, dancing, and the like) of a subject, optionally, asubject having an impaired lower extremity. For example, a system forfacilitating ambulation of a subject may include a walking braceconfigured to suspend a subject's lower extremity (e.g., foot) in anon-weight-bearing position. In some embodiments, a system may transferthe subject's weight to at least a portion of the subject's lower legand/or to at least a portion of the subject's upper leg. Aweight-bearing portion of the lower leg may have a vertical span fromabout the gastrocnemius/solius muscles to about the tibial plateau. Aweight-bearing portion of the upper leg may have a vertical span fromjust superior to the patella to about the proximal one third of thequadriceps femoris. A lower cuff may span up to the entire circumferenceof a subject's lower leg. An upper cuff may span up to the entirecircumference of a subject's upper leg. When positioned upright, asubject's foot may dangle loosely. The subject's impaired lowerextremity may have a wound dressing, a cast, a wrap, or other dressingsor garments. With respect to a cast (and/or any other rigid and/or semirigid material), care may be taken to ensure that the cast does not bearany weight since that load may be transmitted to a subject's foot. Forexample, a device may be adapted to accommodate a subject wearing a castthat covers the subject's ankle and extends up to about the mid-calfregion (e.g., by shortening the lower cuff by an amount sufficient toensure that weight is not transferred from the brace to the cast). Itmay be desirable, in some embodiments, to include a covering and/orsling to protect and support a lower extremity. The choice of coveringand/or sling may be influenced by the nature of the impairment and/orthe nature of the dressing.

For example, it may be desirable to support and/or immobilize asubject's foot in a position that is generally perpendicular to the axisof the lower leg (e.g., to prevent and/or minimize Achilles tendoncontracture). For example, a sling attached (e.g., by a slide, spring oradjustable canvas component to avoid permitting the foot to bear weight)to at least one cuff and/or at least one strut may be used to secure asubject's foot in this position. In one example, the sling may surroundthe foot making contact at or in the general region of the arch. Inother examples, the sling may surround the foot, making contact at theheel or the ball of the foot. The portion in contact with the foot maybe of any useful material including, but not limited to, syntheticfabrics, plastics, foams (e.g., P-Cell foam), and natural products likecotton or wool. For example, polyurethane, polyethylene, neoprene,ethylene vinyl acetate, silicone, rubber, and combinations thereof maybe used. If the sling is attached to the cuff and/or strut using acanvas component, the canvas length may be adjusted using any meansknown in the art including buckles, snaps and the like to provide thefoot with the desired tension. According to some embodiments, a slingmay partially or completely surround a lower extremity (e.g., a foot). Asling, in some embodiments, may be configured like an ordinary sock. Asling may be attached (e.g., removably attached) to a lower extremitybrace (e.g., to a cuff, a strutt, platform, and/or elsewhere). Accordingto some embodiments, a platform may be fitted with one or more pads onits upper surface with the pad positioned, for example, under the ballof the foot or over the entire platform. A foot pad, in someembodiments, may be scored or perforated into segments to allow a healthcare worker or a subject to customize the support as needed. Forexample, it may be desirable to minimize Achilles tendon contracture ina subject with an open sore (e.g., diabetic foot ulcer) by providingfoot support that does not contact the open sore. Segments of the padmay be selectively removed to avoid that contact. A pad and/or a slingmay comprise, according to some embodiments, one or more linersincluding, for example, a cushioned liner (e.g., a Spenco® liner), asilicon liner, and/or combinations thereof A lower extremity brace for asubject having or at risk of having a diabetic foot ulcer, for example,may include a sling with a Spenco® liner and an additional, internal,silicon liner.

According to some embodiments, an impairment of a lower extremity mayinclude a foot impairment, an ankle impairment, and/or a kneeimpairment. An impairment may affect a subject's ability to bear weighton or near the effected region. According to some embodiments, animpairment of a lower extremity may include any condition that makes itundesirable for a subject to bear weight on the extremity. For example,an impairment may exist where the pathology itself impedes the weightbearing capacity. An impairment may also exist where therapy,convalescence, and/or rehabilitation include relieving the region ofweight-bearing forces. Examples of lower extremity impairments mayinclude, without limitation, a fractured bone, a broken bone, a sprain,an ulcer (e.g., a diabetic ulcer), an amputation, a suture (e.g., on adistal end of an extremity such as the bottom of a foot or the terminusof a residual limb after an amputation), arthritis, a joint dislocation,a joint subluxation, a torn ligament (e.g., a torn anterior cruciateligament), a torn cartilage (e.g., a torn meniscus), bursitis,tendonitis, an infection, gout, gangrene, plantar fasciitis, metabolicdiseases, bone or cartilage diseases, neuropathic states and/orpost-operative states. With regard to amputation, a lower extremitybrace may be used, according to some embodiments, as an intermediatestep device prior to a permanent below the knee prosthesis, such aswaiting for the maturing of the residual limb. In some embodiments, alower extremity brace may be used as a permanent, below-the-kneeprosthesis, for example, those with a very low amputation. A lowerextremity brace may be used as a temporary prosthesis for those withresidual limb wounds, or those with residual limb breakdown in someembodiments. A lower extremity brace may be used as a post operativeprotector with a thigh component spanning above the knee to reducecontracture while the brace increases compression to reduce swelling andimprove healing. A thigh segment may be removed or articulated below theknee joint to allow for early ambulation of the amputee while the opendistal end of the brace will provide relief for the suture site.

In some embodiments, increased ambulation may reduce, eliminate, and/orprevent one or more conditions, including, for example, deep venousthrombosis, atrophy, pain (e.g., lower back pain due to bed rest),and/or osteoporosis or other bone loss. Increasing a subject'sambulation without crutches may decrease the incidence of injuriesassociated with falling and/or upper body strain.

A load redistribution system, in some embodiments, may include aplatform, at least one vertical strut fixed to the platform, and atleast one cuff fixed to the at least one vertical strut. In someembodiments, one or more fasteners may be used to secure a loadredistribution system to a subject's leg including, for example, belts,buckles (e.g., ski boot buckles, ratcheting buckles), buttons, cams,carabineers, chains, cinches, clasps, D-rings, draw-strings, hooks,levers, locks, loops, slides, snaps, straps, and/or tensioners. Thesefasteners may be attached to the at least one vertical strut and/or theat least one cuff In some embodiments, alignment or guide pins may beused in the at least one cuff to guide cuff components into properalignment with each other and to provide further support for the devicewhen it is surrounding the circumference of at least a portion of thesubject's leg. For example, a system comprising two cuffs configured tocontact each other along at least one edge, may include one or moreguide pins (e.g., positioned generally perpendicular to the at least oneedge) on one cuff and corresponding guide apertures (e.g., sleeves) onthe other cuff In some embodiments, a guide pin may slide releasably ina corresponding guide aperture. A system may include any desired orrequired number of guide pins and corresponding guide apertures (e.g.,from about 1 pair to about 20 pairs). According to some embodiments, allguide pins may be arranged on one cuff and all guide apertures may belocated on a facing cuff In some embodiments, a mixture of guide pinsand apertures may be arranged on one cuff with the corresponding guideapertures and guide pins arranged on the other cuff One or more guidepins and corresponding guide apertures may be included in a systemhaving a single cuff (e.g., a hinged cuff or clam-shell cuff).

According to some embodiments, a load redistribution system may beconfigured to bear and/or redistribute a load (e.g., a subject'sweight). For example, a load redistribution system may be configured totransfer the load of s subject's weight away from the subject's foot andtransfer it to the subject's lower and/or upper leg. A loadredistribution system may comprise one or more struts positionedadjacent to a subject's leg (e.g., in front of, behind, to the right, ofand/or to the left of a subject's leg). For example, a single strut maybe positioned on the left side of a left leg, on the right side of aright leg, or behind a left leg or right leg. In some embodiments, astrut may be positioned on the generally opposite side of a leg from asubject's sagittal plane or on the generally opposite side of a leg froma subject's coronal plane. In some embodiments, a strut positionedgenerally behind the subject's leg on which the system is worn may havean S-curve profile. For example, a strut may be configured to have aprofile that resembles a letter “S” in that it has two opposinginflection points (e.g., one anterior and one posterior). An S-curveprofile may permit clearance for a subject's foot and/or a normalstride.

A strut may comprise, according to some embodiments, two pieces (e.g.,an upper piece and a lower piece) joined by a hinge. In someembodiments, a hinge may be configured to permit a limited range (e.g.,limited flexion and/or extension) and/or an unlimited range ofrotational motion. According to some embodiments, a two-strut system mayhave a strut on each side of a subject's leg, with each strut having asingle piece (e.g., lower leg only) or two pieces connected by a hinge(e.g., a full leg brace).

According to some embodiments, a load redistribution system may beconfigured to bear a load. A load may include, for example, a subject'sweight, a portion of a subject's weight, and/or a multiple of asubject's weight (e.g., 1.1×, 1.2×, 1.5×, and/or 2×). It may bedesirable for a load redistribution system to bear a more than asubject's weight, for example, where the subject may carry additionalweight (e.g., a backpack, a bag of groceries, a child, and/or the like)and/or may put the system under additional stress (e.g., through sport,exercise, or the like). In some embodiments, a subject's lower extremity(e.g., foot) with a load redistribution system in place bears little orno weight, even though weight is born by that leg (e.g., while standing,exercising, working, and/or engaging in other activities).

A load redistribution system may include at least one cuff fixed to atleast one strut in some embodiments. For example, a system may include alower leg cuff and an upper leg cuff. A system may include a pluralityof lower cuffs and/or a plurality of upper cuffs in some embodiments.For example, if a single cuff would contact and/or cover an injuredportion of a lower leg, it may be desirable to instead use two or morelower cuffs configured to minimize and/or avoid contacting/covering theaffected region. A cuff may be fixedly or adjustably mounted to acorresponding strut in some embodiments. For example, a strut mayinclude a series of holes (e.g., equidistantly spaced) configured toreceive a corresponding pin (e.g., spring-loaded) and/or screw attachedto a cuff. A user may slide the cuff along the length of a strut andengage the screw and/or pin when a desired position is found. In someembodiments, a load redistribution system may include continuouslyvariable adjustment system. A cuff may slide along the length of a strutwith one or more set screws configured to fix the relative positions ofeach once a desirable position is found.

In some embodiments, a cuff may include a pad disposed to contact atleast a portion of a subject's leg and an outer shell. An inner pad maycomprise any desirable gel, foam (e.g., P-Cell foam), and/or othercushioning material(s). A custom fit cuff may facilitate, according tosome embodiments, uniform distribution (e.g., uniform, substantiallyuniform, relatively uniform) of a subject's weight over the surface areaof the cuff. An outer shell may comprise a moldable material.

In some embodiments, a cuff may be opened on at least one side tofacilitate donning and/or removing the cuff (and attached loadredistribution system). For example, a cuff may comprise two outershells with one or more hinges arranged on one side to allow the cuff toopen clamshell-style. Two or more outer shells may fit together withouta hinge or other permanent connection according to some embodiments.Once donned, a cuff may be closed and/or secured using any type of fixedor adjustable tensioning system. For example, one or more collars,straps, cinches, guides, loops, hooks, hoops, buckles, and/orcombinations thereof may be used. In some embodiments, a tensioningsystem may include hooks and/or loops (e.g., VELCRO®).

According to some embodiments, a load redistribution system, whendonned, will increase a subject's inseam. This may result in anundesirable difference between the inseam of the leg on which a loadredistribution system is worn and the inseam of the free leg. Anydifference may be offset, at least partially, by wearing a lift (e.g.,integrated and/or inserted in a shoe) or other apparatus on the freeleg.

FIGS. 1A-1D illustrate an example of a load redistribution system 101for ambulation of a subject having a lower extremity impairment, inaccordance with embodiments of the present disclosure. As shown in FIGS.1A-1D, load redistribution system 101 may include outsole 104, platform106, lower strut 108, lower cuff 110, hinge 136, upper strut 138, andupper cuff 140.

Outsole 104 may comprise a foot pad, the bottom of which may be rounded(e.g., rocker outsole) to facilitate walking. The bottom may be ridgedas pictured or may have another tread pattern to aid ambulation. Outsole104 may comprise a hard rubber or other suitable material. Outsole 104may be generally rectangular in shape as depicted. Other regular and/orirregular shapes may be suitable and/or desirable in some embodiments.Platform 106 may be contiguous with lower strut 108 as shown or may be aseparate piece fixedly attached (e.g., welded, bolted) to lower strut108. In some embodiments, outsole 104 and platform 106 may be adjustable(e.g., fore and aft) relative to each other. The lower surface ofplatform 106 may be affixed to outsole 104 with any type of fastenerand/or adhesive. Platform 106 may sit atop outsole 104 as shown. In someembodiments, platform 106 may be recessed within outsole 104, forexample, so that the upper surface of outsole 104 is flush with theupper surface of platform 106. Platform 106 may have any regular orirregular shape. Platform 106 may be somewhat smaller than outsole 104as depicted or may be sized to match the size of outsole 104. In someembodiments, it may be desirable for platform 106 to be larger thanoutsole 104. Platform 106 may comprise a rigid material suitable forbearing a subject's weight. Examples of such materials include, withoutlimitation, steel, a steel alloy, aluminum, an aluminum alloy, titanium,a titanium alloy, carbon fiber, wood, an aramid fiber, a para-aramidfiber (e.g., KEVLAR), fiberglass, and combinations thereof.

Lower strut 108 may extend vertically from platform 106 to hinge 136.Upper strut 138 may extend vertically from hinge 136 to a positioncorresponding to or just below a subject's hip. Lower strut 108 may havea lengthwise axis that is approximately parallel to the lengthwise axisof a subject's leg (e.g., lower leg). Upper strut 138 may have alengthwise axis that is approximately parallel to the lengthwise axis ofa subject's leg (e.g., upper leg). Lower strut 108 and/or upper strut138 may comprise one or more rigid materials capable of bearing asubject's weight. Examples of such materials include, withoutlimitation, steel, a steel alloy, aluminum, an aluminum alloy, titanium,a titanium alloy, carbon fiber, wood, an aramid fiber, a para-aramidfiber (e.g., KEVLAR), fiberglass, and combinations thereof.

As depicted, lower cuff 110 may comprise anterior pad 112, anterior padshell 114, posterior pad 116, posterior pad shell 118, calf collar 120,and tension adjustment fastener 126. Pads 112 and/or 116 mayindependently comprise flexible, elastomeric, and/or resilient materialsincluding, for example, polyurethane, polyethylene, neoprene, ethylenevinyl acetate, foam (e.g., P-Cell foam), silicone, rubber, and the like.Pad shells 114 and/or 118 may independently comprise a moldable plastic.In some embodiments, pad shells 114 and/or 118 may independentlycomprise steel, a steel alloy, aluminum, an aluminum alloy, titanium, atitanium alloy, carbon fiber, an aramid fiber, a para-aramid fiber(e.g., KEVLAR), fiberglass, and combinations thereof Pad shells 114and/or 118 comprising a moldable material may be custom fit to asubject. A moldable plastic may include, for example, a thermoplastic(e.g., capable of more than one cycle of melting, molding, and setting)and/or a thermosetting plastic (e.g., capable of one cycle of melting,molding, and setting). Pads 112 and/or 116 may be adhered, welded,bonded, stitched, or otherwise fixed to pad shells 114 and/or 118,respectively.

Pad shells 114 and/or 118 may be fixedly attached to calf collar 120.Calf collar 120 may extend up to all the way around the circumference ofa subject's lower leg. Calf collar 120 may include sleeve 122positioned, for example, at or near its midpoint. Sleeve 122 may beconfigured to receive strut 108. Sleeve 122 may have a cavity, thelongitudinal axis of which is about perpendicular to the lengthwise axisof strut 108. Sleeve 122 may be configured to allow collar 120 to slidealong the length of strut 108. Sleeve 122 may include set screw 124positioned to adjustably contact strut 108. Each calf collar may beconfigured to include a sleeve and each sleeve may include a set screw.In use, set screw 124 may be loosened to permit collar 120 to slidealong the length of strut 108. Once a desirable position is found, setscrew 124 may be tightened to fix the position of collar 120 on strut108. Set screw 124 may be positioned on the inside of collar 120 anddirected outwardly toward strut 108 as shown. In some embodiments, setscrew 124 may be positioned on the outside of collar 120 and directedinwardly toward strut 108. As depicted, lower cuff 110 may include threecalf collars 120. In some embodiments, more or fewer collars may bedesired and/or required.

Tension adjustment fastener 126 may include strap 128, cinch 130, andanchor 132. Strap 128 maybe fixed to one end of calf collar 120 viaanchor 132. Cinch 130 may be fixed to the other end of collar 120. Cinch130 may be configured to receive and releasably grip strap 128. In use,strap 128 may be threaded through cinch 130 and pulled tight to apply adesired amount of pressure on the subject's lower leg. Cinch 130 maythen be closed to fix strap 128 in its position. As depicted, the looseend of strap 120 may be tucked into anchor 132.

Hinge 136 may link lower strut 108 and upper strut 138 and permitrotation of lower strut 108 and upper strut 138 relative to each other.When system 101 is in position on a subject's leg, the hinge axis ofhinge 136 may be parallel or substantially parallel to the hinge axis ofthe subject's knee in good health. It may be desirable, in someembodiments, to configure hinge 136 to have a limited and/or selectabledegree of rotation (e.g., flexion and/or extension).

As depicted, upper cuff 140 may comprise anterior pad 142, anterior padshell 144, posterior pad 146, posterior pad shell 148, thigh collar 150,and tension adjustment fastener 156. Pads 142 and/or 146 mayindependently comprise flexible, elastomeric, and/or resilient materialsincluding, for example, polyurethane, polyethylene, neoprene, ethylenevinyl acetate, foam (e.g., P-Cell foam), silicone, rubber, and the like.

In some embodiments, pad shells 144 and/or 148 may independentlycomprise a moldable plastic, steel, a steel alloy, aluminum, an aluminumalloy, titanium, a titanium alloy, carbon fiber, an aramid fiber, apara-aramid fiber (e.g., KEVLAR), fiberglass, and combinations thereof.Pad shells 144 and/or 148 comprising a moldable material may be customfit to a subject. A moldable plastic may include, for example, athermoplastic (e.g., capable of more than one cycle of melting, molding,and setting) and/or a thermosetting plastic (e.g., capable of one cycleof melting, molding, and setting). Pads 142 and/or 146 may be adhered,welded, bonded, stitched, or otherwise fixed to pad shells 144 and/or148, respectively.

Pad shells 144 and/or 148 may be fixedly attached to thigh collar 150.Thigh collar 150 may extend up to all the way around the circumferenceof a subject's upper leg. Thigh collar 150 may include sleeve 152positioned, for example, at or near its midpoint. Sleeve 152 may beconfigured to receive strut 138. Sleeve 152 may have a cavity, thelongitudinal axis of which is about perpendicular to the lengthwise axisof strut 138. Sleeve 152 may be configured to allow collar 150 to slidealong the length of strut 138. Sleeve 152 may include set screw 154positioned to adjustably contact strut 138. In use, set screw 154 may beloosened to permit collar 150 to slide along the length of strut 138.Once a desirable position is found, set screw 154 may be tightened tofix the position of collar 150 on strut 138. Set screw 154 may bepositioned on the inside of collar 150 and directed outwardly towardstrut 138 as shown. In some embodiments, set screw 154 may be positionedon the outside of collar 150 and directed inwardly toward strut 138. Asdepicted, upper cuff 140 may include three thigh collars 150. In someembodiments, more or fewer collars may be desired and/or required.

Tension adjustment fastener 156 may include strap 158, cinch 160, andanchor 162. Strap 158 maybe fixed to one end of thigh collar 150 viaanchor 162. Cinch 160 may be fixed to the other end of collar 150. Cinch160 may be configured to receive and releasably grip strap 158. In use,strap 158 may be threaded through cinch 160 and pulled tight to apply adesired amount of pressure on the subject's upper leg. Cinch 160 maythen be closed to fix strap 158 in its position. As depicted, the looseend of strap 150 may be tucked into anchor 162.

FIGS. 2A-2B illustrate an example load redistribution system 201 forambulation of a subject having a lower extremity impairment, inaccordance with embodiments of the present disclosure. As shown in FIGS.2A-2B, system 201 may be configured (e.g., formed and/or adjusted) toinclude gap 275 between a subject's foot 272 and the higher of outsole204 and platform 206. Gap 275 relieves subject's foot 272 and/or otherlower extremities from bearing weight by diverting the load elsewhere.In some embodiments, gap 275 may be any suitable distance that avoids(e.g., minimizes, eliminates) loading foot 272 and/or other lowerextremities. Gap 275 may depend, in part, upon the size and weight ofthe subject user. For example, a subject with a long foot may beinclined and/or compelled to support some weight on foot 272 at somepoints in a walking cycle (e.g., when foot 272 is at it's most rearwardposition). It may be desirable in such situations to adjust gap 275 tobe larger. A subject, for example, a smaller subject, may desire and/orrequire a smaller gap 675, for example, to reduce or minimize thedifference in length between the effected leg with system 602 and ahealthy leg. In some embodiments, gap 275 may be from about 1 cm toabout 5 cm, from about 1 cm to about 15 cm, from about 1 cm to about 10cm, from about 1 cm to about 20 cm, from about 2 cm to about 5 cm, fromabout 2 cm to about 10 cm, from about 2 cm to about 15 cm, and/or fromabout 2 cm to about 20 cm. Gap 275 may be less than about 1 cm or morethan 20 cm in some embodiments.

FIGS. 3A-3D illustrate an example of a load redistribution system 302for ambulation of a subject having a lower extremity impairment, inaccordance with embodiments of the present disclosure. As shown in FIGS.3A-3D, load redistribution system 302 may include outsole 304, platform306, lower strut 308, and lower cuff 310.

Outsole 304 may comprise a foot pad, the bottom of which may be rounded(e.g., rocker outsole) to facilitate walking. The bottom may be ridgedas pictured or may have another tread pattern to aid ambulation. Outsole304 may comprise a hard rubber or other suitable material. Outsole 304may be generally rectangular in shape as depicted. Other regular and/orirregular shapes may be suitable and/or desirable in some embodiments.Platform 306 may be contiguous with strut 308 as shown or may be aseparate piece fixedly attached to strut 308. The lower surface ofplatform 306 may be affixed to outsole 304 with any type of fastenerand/or adhesive. Platform 306 may sit atop outsole 304 as shown. In someembodiments, platform 306 may be recessed within outsole 304, forexample, so that the upper surface of outsole 304 is flush with theupper surface of platform 306. Platform 306 may have any regular orirregular shape. Platform 306 may be somewhat smaller than outsole 304as depicted or may be sized to match the size of outsole 304. In someembodiments, it may be desirable for platform 306 to be larger thanoutsole 304. Platform 306 may comprise a rigid material suitable forbearing a subject's weight. Examples of such materials include, withoutlimitation, steel, a steel alloy, aluminum, an aluminum alloy, titanium,a titanium alloy, carbon fiber, wood, an aramid fiber, a para-aramidfiber (e.g., KEVLAR), fiberglass, and combinations thereof.

Strut 308 may extend vertically from platform 306 to hinge to a positioncorresponding to or just below a subject's tibia. Strut 308 may have alengthwise axis that is approximately parallel to the lengthwise axis ofa subject's leg (e.g., lower leg). Strut 308 may comprise one or morerigid materials capable of bearing a subject's weight. Examples of suchmaterials include, without limitation, steel, a steel alloy, aluminum,an aluminum alloy, titanium, a titanium alloy, carbon fiber, wood, anaramid fiber, a para-aramid fiber (e.g., KEVLAR), fiberglass, andcombinations thereof.

As depicted, lower cuff 310 may comprise anterior pad 312, anterior padshell 314, posterior pad 316, posterior pad shell 318, calf collar 320,and tension adjustment fastener 326. Pads 312 and/or 316 mayindependently comprise flexible, elastomeric, and/or resilient materialsincluding, for example, polyurethane, polyethylene, neoprene, ethylenevinyl acetate, foam (e.g., P-Cell foam), silicone, rubber, and the like.In some embodiments, pad shells 314 and/or 318 may independentlycomprise a moldable plastic, steel, a steel alloy, aluminum, an aluminumalloy, titanium, a titanium alloy, carbon fiber, an aramid fiber, apara-aramid fiber (e.g., KEVLAR), fiberglass, and combinations thereof.Pad shells 314 and/or 318 comprising a moldable material may be customfit to a subject. A moldable plastic may include, for example, athermoplastic (e.g., capable of more than one cycle of melting, molding,and setting) and/or a thermosetting plastic (e.g., capable of one cycleof melting, molding, and setting). Pads 312 and/or 316 may be adhered,welded, bonded, stitched, or otherwise fixed to pad shells 314 and/or318, respectively.

Pad shells 314 and/or 318 may be fixedly attached to calf collar 320.Calf collar 320 may extend up to all the way around the circumference ofa subject's lower leg. Calf collar 320 may include sleeve 322positioned, for example, at or near its midpoint. Sleeve 322 may beconfigured to receive strut 308. Sleeve 322 may have a cavity, thelongitudinal axis of which is about perpendicular to the lengthwise axisof strut 308. Sleeve 322 may be configured to allow collar 320 to slidealong the length of strut 308. Sleeve 322 may include set screw 324positioned to adjustably contact strut 308. Each calf collar may beconfigured to include a sleeve and each sleeve may include a set screw.In use, set screw 324 may be loosened to permit collar 320 to slidealong the length of strut 308. Once a desirable position is found, setscrew 324 may be tightened to fix the position of collar 320 on strut308. Set screw 324 may be positioned on the inside of collar 320 anddirected outwardly toward strut 308 as shown. In some embodiments, setscrew 324 may be positioned on the outside of collar 320 and directedinwardly toward strut 308. As depicted, lower cuff 310 may include threecalf collars 320. In some embodiments, more or fewer collars may bedesired and/or required.

Tension adjustment fastener 326 may include strap 328, cinch 330, andanchor 332. Strap 328 maybe fixed to one end of calf collar 320 viaanchor 332. Cinch 330 may be fixed to the other end of collar 320. Cinch330 may be configured to receive and releasably grip strap 328. In use,strap 328 may be threaded through cinch 330 and pulled tight to apply adesired amount of pressure on the subject's lower leg. Cinch 330 maythen be closed to fix strap 328 in its position. As depicted, the looseend of strap 320 may be tucked into anchor 332.

FIG. 4 illustrates an example of a load redistribution system 403 forambulation of a subject having a lower extremity impairment, inaccordance with embodiments of the present disclosure. As shown in FIG.4, load redistribution system 403 may include lower cuff 410, upper cuff440, and rod assembly 480.

Lower cuff 410, as shown, may include anterior pad 412, anterior padshell 414, calf collar 420, and tension adjustment fastener 426. Lowercuff 410 may be secured on a subject's lower leg in a manner similar tocuffs 110 and 310. Upper cuff 440, as shown, may include, posterior pad446, posterior pad shell 448, calf collar 450, and tension adjustmentfastener 456. Upper cuff 440 may be secured on a subject's upper leg ina manner similar to cuffs 140 and 340. Rod assembly 480, as shown, mayinclude foot 482, vertical rod 484, and lateral bar 486.

Lateral bar 486 may be fixed to lower cuff 410 at one end and fixed tovertical rod 484 at the other as shown. In some embodiments, a lowercuff may be fixed directly to a vertical rod allowing the lateral bar tobe omitted. Upper cuff 440 may be fixed directly to vertical rod 484. Insome embodiments, a lateral bar may be interposed between an upper cuffand a vertical rod. Rod assembly 480 may comprise one or more rigidmaterials capable of bearing a subject's weight. Examples of suchmaterials include, without limitation, steel, a steel alloy, aluminum,an aluminum alloy, titanium, a titanium alloy, carbon fiber, wood,fiberglass and combinations thereof.

Variations in the weight of a subject, the positioning of the cuff(s),and/or the dimensions of the cuff(s) may influence the pressure on asubject's leg. In some embodiments, the pressure applied by a cuff on asubject's leg may be up to about 5 psi, up to about 7.5 psi, up to about10 psi, up to about 15 psi, up to about 20 psi, up to about 25 psi,and/or up to about 30 psi. In some embodiments, a system may include oneor more sensors (e.g., pressure sensors). One or more sensors configuredto detect the pressure at a particular location and/or the load bornand/or or shifted.

FIGS. 5A and 5B illustrate an example of a load redistribution system501 for ambulation of a subject having a lower extremity impairment, inaccordance with embodiments of the present disclosure. As shown in FIG.5A, load redistribution system 501 may support a subject's weightthrough lower strut 508 (not expressly shown), lower cuff 510(comprising circumferential pad 511), upper strut 538 (not expresslyshown), and upper cuff 540 (comprising circumferential pad 541). FIG. 5Aillustrates a method for calculating the pressure to be applied to asubject's leg as system 501 bears a subject's weight. Subject's weightis represented as vector V. As depicted, pads 511 and 541 are positionedat an angle θ relative to vector V. The force applied to pad 511 isrepresented as vector F_(P1) and the force applied to pad 511 isrepresented as vector F_(P2). The horizontal component of vector F_(P1)is represented by vector F_(X1) and the vertical component isrepresented by vector F_(Y1). The horizontal component of vector F_(P2)is represented by vector F_(X2) and the vertical component isrepresented by vector F_(Y2). Since system 501 is configured to bear asubject's full weight (w),

w=F _(Y1) +F _(Y2)   (Equation 1)

If the subject's weight (w) is distributed evenly between pads 511 and541,

w/2=F _(Y1) =F _(Y2)   (Equation 2)

Thus, since

sin(θ)=F _(Y1) /F _(P1)   (Equation 3)

the force F_(P1) applied to a subject's leg may be calculated asfollows:

F _(P1) =F _(Y1)/sin(θ)   (Equation 4)

The area of cuff 510 is given by Equation 5:

Area=[(d ₁ +d ₂)/2]*L*π  (Equation 5)

Thus, the pressure (P) on a subject's leg at cuff 510 is given byEquation 4:

$\begin{matrix}{P = \frac{F_{Y\; 1}/{\sin (\theta)}}{\left\lbrack {\left( {d_{1} + d_{2}} \right)/2} \right\rbrack*L*\pi}} & \left( {{Equation}\mspace{14mu} 6} \right)\end{matrix}$

Therefore, if pad 511 is positioned at an angle of 7° (θ), d₁ is 5.41inches, d₂ is 3.5 inches, L is 7 inches, and the subject's weight is 180pounds, the pressure (P) is given by

$\begin{matrix}{P = \frac{\left( {w/2} \right)/{\sin (\theta)}}{\left\lbrack {\left( {d_{1} + d_{2}} \right)/2} \right\rbrack*L*\pi}} & \left( {{Equation}\mspace{14mu} 7} \right) \\{{P = \frac{\left( {180/2} \right)/{\sin (7)}}{\left\lbrack {\left( {5.41 + 3.5} \right)/2} \right\rbrack*7*\pi}}{P = {7.5\mspace{14mu} {psi}}}} & \left( {{Equation}\mspace{14mu} 8} \right)\end{matrix}$

FIGS. 6A-6H illustrate an example of a load redistribution system 602for ambulation of a subject having a lower extremity impairment, inaccordance with embodiments of the present disclosure. As shown in FIGS.6A-6H, load redistribution system 602 may include outsole 604, platform606, strut 608, support 690, and cuff 610.

Outsole 604 may comprise a foot pad, the bottom of which may be rounded(e.g., rocker outsole) to facilitate walking. The bottom may be ridgedas pictured or may have another tread pattern to aid ambulation. Outsole604 may comprise a hard rubber or other suitable material. Outsole 604may be generally rectangular in shape as depicted. Other regular and/orirregular shapes may be suitable and/or desirable in some embodiments.Platform 606 may be contiguous with strut 608 as shown or may be aseparate piece fixedly attached to strut 608. In some embodiments,outsole 604 and platform 606 may be adjustable (e.g., fore and aft)relative to each other. The lower surface of platform 606 may be affixedto outsole 604 with any type of fastener and/or adhesive. Platform 606may sit atop outsole 604 as shown. In some embodiments, platform 606 maybe recessed within outsole 604, for example, so that the upper surfaceof outsole 604 is flush with the upper surface of platform 606. Platform606 may have any regular or irregular shape. Platform 606 may besomewhat smaller than outsole 604 as depicted or may be sized to matchthe size of outsole 604. In some embodiments, it may be desirable forplatform 606 to be larger than outsole 604. Platform 606 may comprise arigid material suitable for bearing a subject's weight. Examples of suchmaterials include, without limitation, steel, a steel alloy, aluminum,an aluminum alloy, titanium, a titanium alloy, carbon fiber, wood, anaramid fiber, a para-aramid fiber (e.g., KEVLAR), fiberglass, andcombinations thereof.

System 602 may include strut 608 positioned substantially behind asubject's leg when the leg is secured in system 602. At least a portionof strut 608 may be fixedly connected to and/or contiguous with aposterior portion of platform 606. At least a portion of strut 608extends from a posterior portion of platform 606 in the same plane asplatform 606 or a plane generally parallel to the plane of platform 606(“horizontal” portion). At least a portion of strut 608 rises above theplane of platform 606 and generally perpendicular to the plane ofplatform 606 (“vertical” portion). This vertical portion may have alengthwise axis that is approximately parallel to the lengthwise axis ofa subject's leg (e.g., lower leg). Strut 608 may include bend 607interposed between the horizontal and vertical portions of strut 608.Bend 607 may be configured to bend or curve upward from platform 606 ina manner that permits a subject a normal or generally normal stride(e.g., heel to toe contact with the ground). Strut 608 may comprise oneor more rigid materials capable of bearing a subject's weight. Examplesof such materials include, without limitation, steel, a steel alloy,aluminum, an aluminum alloy, titanium, a titanium alloy, carbon fiber,wood, an aramid fiber, a para-aramid fiber (e.g., KEVLAR), fiberglass,and combinations thereof While strut 608 may be rigid to support asubject's weight, some resilience/flexibility may be tolerated and/ordesirable in some embodiments.

As depicted, cuff 610 may comprise anterior pad 612, anterior pad shell614, posterior pad 616, posterior pad shell 618, and tension adjustmentfastener 626. Pad 612 may include one or more apertures 613. Shell 614may include one or more apertures 615. Pad 616 may include one or moreapertures 617. Shell 618 may include one or more apertures 619. Padapertures 613 and 617 may be independently aligned (e.g., partially orcompletely) with shell apertures 615 and 619, respectively. Pads 612and/or 616 may independently comprise flexible, elastomeric, and/orresilient materials including, for example, polyurethane, polyethylene,neoprene, ethylene vinyl acetate, foam (e.g., P-Cell foam), silicone,rubber, and the like. Pad shells 614 and/or 618 may independentlycomprise a moldable plastic. In some embodiments, pad shells 614 and/or618 may independently comprise steel, a steel alloy, aluminum, analuminum alloy, titanium, a titanium alloy, carbon fiber, an aramidfiber, a para-aramid fiber (e.g., KEVLAR), fiberglass, and combinationsthereof. Pad shells 614 and/or 618 comprising a moldable material may becustom fit to a subject. A moldable plastic may include, for example, athermoplastic (e.g., capable of more than one cycle of melting, molding,and setting) and/or a thermosetting plastic (e.g., capable of one cycleof melting, molding, and setting). Pads 612 and/or 616 may be adhered,welded, bonded, stitched, or otherwise fixed to pad shells 614 and/or618, respectively.

As shown in FIG. 6C, pad shell 618 may be fixedly attached to support690. Pad shells 614 and 618 may be attached to each other through one ormore hinges 633. Support 690 may be attached to strut 608—one or morescrews 624 may be secured to support 690 through one or more holes 625in strut 608. As shown in FIG. 6C, a plurality of holes 625 along avertical axis of strut 608 affords a health care worker and/or a subjectthe opportunity to adjust the height of cuff 610.

Tension adjustment fastener 626 may include strap 628, cinch 630, andanchor 632. Strap 628 maybe fixed to posterior pad shell 618 via anchor632. Cinch 630 may be fixed to posterior pad shell 618 at a point alongthe circumference of shell 618 and spaced away from anchor 632. Cinch630 may be configured to receive and releasably grip strap 628. In use,strap 628 may be threaded through cinch 630 and pulled tight to apply adesired amount of pressure on the subject's lower leg. Cinch 630 maythen be closed to fix strap 628 in its position. System 602 may includeone, two (pictured), three or more tension adjustment fasteners 626.

FIG. 6B illustrates an example load redistribution system 602 forambulation of a subject having a lower extremity impairment, inaccordance with embodiments of the present disclosure. As shown in FIG.6B, system 602 may be configured (e.g., formed and/or adjusted) toinclude gap 675 between a subject's foot 672 and the higher of outsole604 and platform 606. Gap 675 relieves subject's foot 672 and/or otherlower extremities from bearing weight by diverting at least a portion ofthe load elsewhere (e.g., all or substantially all of the load). In someembodiments, gap 675 may be any suitable distance that avoids (e.g.,minimizes, eliminates) loading foot 672 and/or other lower extremities.The extent of gap 675 may depend, in part, upon the size and weight ofthe subject user. For example, a subject with a long foot may beinclined and/or compelled to support some weight on foot 672 at somepoints in a walking cycle (e.g., when foot 672 is at it's most rearwardposition with the toes nearest the ground and the heal elevated). It maybe desirable in such situations to adjust gap 675 to be larger. Asubject, for example, a smaller subject, may desire and/or require asmaller gap 675, for example, to reduce or minimize the difference inlength between the effected leg with system 602 and a healthy leg. Insome embodiments, gap 675 may be from about 1 cm to about 5 cm, fromabout 1 cm to about 15 cm, from about 1 cm to about 10 cm, from about 1cm to about 20 cm, from about 2 cm to about 5 cm, from about 2 cm toabout 10 cm, from about 2 cm to about 15 cm, and/or from about 2 cm toabout 20 cm. Gap 675 may be less than about 1 cm or more than 20 cm insome embodiments.

FIGS. 7A-7H illustrate an example of a load redistribution system 702for ambulation of a subject having a lower extremity impairment, inaccordance with embodiments of the present disclosure. As shown in FIGS.7A-7H, load redistribution system 702 may include outsole 704, pad 705,platform 706, strut 708, support 791, and cuff 710.

Outsole 704 may comprise a foot pad, the bottom of which may be rounded(e.g., rocker outsole) to facilitate walking. The bottom may be ridgedas pictured or may have another tread pattern to aid ambulation. Outsole704 may comprise a hard rubber or other suitable material. Outsole 704may have any regular or irregular shape. For example, outsole 704 may beconfigured to resemble the tread of a running shoe, a dress shoe, and/ora boot. As depicted, outsole 704 may include a flange that extends fromthe plane of the walking surface in a generally vertical direction alongthe back of strut 708. This flange may facilitate traction and/or anormal or improved stride. Other regular and/or irregular shapes may besuitable and/or desirable in some embodiments. Platform 706 may becontiguous with strut 708 as shown or may be a separate piece fixedlyattached to strut 708. In some embodiments, outsole 704 and platform 706may be adjustable (e.g., fore and aft) relative to each other. The lowersurface of platform 706 may be affixed to outsole 704 with any type offastener and/or adhesive. Platform 706 may sit atop outsole 704 asshown. In some embodiments, platform 706 may be recessed within outsole704, for example, so that the upper surface of outsole 704 is flush withthe upper surface of platform 706. Platform 706 may have any regular orirregular shape. Platform 706 may be somewhat smaller than outsole 704as depicted or may be sized to match the size of outsole 704. In someembodiments, it may be desirable for platform 706 to be larger thanoutsole 704. Platform 706 may comprise a rigid material suitable forbearing a subject's weight. Examples of such materials include, withoutlimitation, steel, a steel alloy, aluminum, an aluminum alloy, titanium,a titanium alloy, carbon fiber, wood, an aramid fiber, a para-aramidfiber (e.g., KEVLAR), fiberglass, and combinations thereof.

System 702 may include strut 708 positioned substantially behind asubject's leg when the leg is secured in system 702. At least a portionof strut 708 may be fixedly connected to and/or contiguous with aposterior portion of platform 706. Strut 708 may have an S-shapedprofile as shown in FIG. 7C or it may form and “L” with platform 706(not expressly illustrated). At least a portion of strut 708 extendsfrom a posterior portion of platform 706 in the same plane as platform706 or a plane generally parallel to the plane of platform 706(“horizontal” portion). At least a portion of strut 708 rises above theplane of platform 706 and generally perpendicular to the plane ofplatform 706 (“vertical” portion). This vertical portion may have alengthwise axis that is approximately parallel to the lengthwise axis ofa subject's leg (e.g., lower leg). Strut 708 may include bend 707interposed between the horizontal and vertical portions of strut 708.Bend 707 may be configured to bend or curve upward from platform 706 ina manner that permits a subject a normal or generally normal stride(e.g., heel to toe contact with the ground). Strut 708 may comprise oneor more rigid materials capable of bearing a subject's weight. Examplesof such materials include, without limitation, steel, a steel alloy,aluminum, an aluminum alloy, titanium, a titanium alloy, carbon fiber,wood, an aramid fiber, a para-aramid fiber (e.g., KEVLAR), fiberglass,and combinations thereof While strut 708 may be rigid to support asubject's weight, some resilience/flexibility may be tolerated and/ordesirable in some embodiments.

As depicted, cuff 710 may comprise anterior bladder 712, anterior shell714, posterior bladder 716, posterior shell 718, and tension adjustmentfastener 726. Bladder 712 may include one or more protrusions 713. Shell714 may include one or more apertures 715. Bladder 716 may include oneor more protrusions 717. Shell 718 may include one or more apertures719. Bladder protrusions 713 and 717 may be aligned with shell apertures715 and 719, respectively to reduce or prevent, for example, movement ofbladders relative to shells. Bladders 712 and/or 716 may independentlycomprise flexible, elastomeric, and/or resilient materials including,for example, polyurethane, polyethylene, neoprene, ethylene vinylacetate, foam (e.g., P-Cell foam), silicone, rubber, and the like. Eachbladder may have an inlet (712 a and/or 716 a) and an outlet (712 band/or 716 b). System 702 may be custom fit to a subject by mountingsystem 702 on the subject and subsequently injecting a fill materialinto a bladder inlet (712 a and/or 716 a). Fill material may be injectedin some embodiment until it begins to be released from bladder outlet(712 b and/or 716 b). In some embodiments, a fill material may beflowable (e.g., a liquid) when it enters a bladder. A fill material maylater convert and/or be converted to a resilient, semi-resilient, ornon-resilient gel or non-liquid (e.g., solid) material. Examples of fillmaterials include, for example, foam, spray foam, gel foam, and/orcombinations thereof.

Shells 714 and/or 718 may independently comprise a moldable plastic. Insome embodiments, shells 714 and/or 718 may independently comprisesteel, a steel alloy, aluminum, an aluminum alloy, titanium, a titaniumalloy, carbon fiber, an aramid fiber, a para-aramid fiber (e.g.,KEVLAR), fiberglass, and combinations thereof. Shells 714 and/or 718comprising a moldable material may be custom fit to a subject. Amoldable plastic may include, for example, a thermoplastic (e.g.,capable of more than one cycle of melting, molding, and setting) and/ora thermosetting plastic (e.g., capable of one cycle of melting, molding,and setting). Bladders 712 and/or 716 may be adhered, welded, bonded,stitched, or otherwise fixed to shells 714 and/or 718, respectively.

As shown in FIG. 7B, shell 718 may be fixedly attached to support 791.Support 791 may be attached to strut 708—one or more screws 724 may besecured to support 791 through one or more holes 725 in strut 708. Asshown in FIG. 7B, a plurality of holes 725 along a vertical axis ofstrut 708 affords a health care worker and/or a subject the opportunityto adjust the height of cuff 710.

Tension adjustment fastener 726 may include strap 728, cinch 730, andanchor 732. Strap 728 maybe fixed to posterior shell 718 via anchor 732.Cinch 730 may be fixed to posterior shell 718 at a point along thecircumference of shell 718 and spaced away from anchor 732. Cinch 730may be configured to receive and releasably grip strap 728. In use,strap 728 may be threaded through cinch 730 and pulled tight to apply adesired amount of pressure on the subject's lower leg. Cinch 730 maythen be closed to fix strap 728 in its position. System 702 may includeone, two (pictured), three or more tension adjustment fasteners 726.

FIGS. 7D and 7E illustrate an example load redistribution system 702 forambulation of a subject having a lower extremity impairment, inaccordance with embodiments of the present disclosure. As shown in FIG.7D, system 702 may include pad 705 positioned to apply just enoughpressure to the bottom of a subject's foot (e.g., the toes and/or theball of the foot) to hold it generally perpendicular to the long axis ofthe lower leg (e.g., tibia and/or fibula). As shown in FIG. 7E, one ormore segments of pad 705 may be removed to accommodate the particulardesires or needs of a subject with ulcer 773 or other foot injury. Pad705 may span up to the entire gap 775. Pad 705 may comprise flexible,elastomeric, and/or resilient materials including, for example,polyurethane, polyethylene, neoprene, ethylene vinyl acetate, foam(e.g., P-Cell foam), silicone, rubber, and the like.

FIGS. 7F and 7G illustrate exploded views of an example loadredistribution system 702 for ambulation of a subject having a lowerextremity impairment, in accordance with embodiments of the presentdisclosure. As shown in FIG. 7G, pad shell 718 may include protrusions733 a that complement slots 733 b in pad shell 714. When pad shells 714and 718 come together (e.g., around a subject's leg), protrusions 733 afit into corresponding slots 733 b and may stabilize the pad shellsections relative to each other.

FIG. 7H illustrates an example load redistribution system 702 forambulation of a subject having a lower extremity impairment, inaccordance with embodiments of the present disclosure. As shown in FIG.7H, system 702 may include shell 795 configured to shield and/or protecta subject's foot from incidental contact with other objects. Shell 795may be secured to strut 708 with straps 796 and snaps 797 asillustrated. Additional straps, snaps, and/or other fasteners may beadded to secure shell 795 (e.g., between shell 795 and outsole 704and/or platform 708.

FIG. 8A illustrates an example load redistribution system 800 forambulation of a subject having a lower extremity impairment, inaccordance with embodiments of the present disclosure. As shown in FIG.8A, system 800 may include a sling 801 configured to secure a subject'sfoot in a particular position (e.g., a non-weight bearing position) forany desirable reason (e.g., patient comfort, protection of an injured ordiseased portion of the foot). The sling 801 may attach to at least onecuff 802 and/or at least one strut 803 and its height may be adjustedusing a buckle 804. Alignment or guide pins 805 may be included to guidecuff components into proper alignment with each other and to providefurther support for the device when it is surrounding the circumferenceof at least a portion of the subject's leg. For example, a systemcomprising two cuffs configured to contact each other along at least oneedge 806, may include one or more guide pins 805 (e.g., positionedgenerally perpendicular to the at least one edge) on one cuff andcorresponding guide apertures 807 (e.g., sleeves) on the other cuff Insome embodiments, a guide pin 805 may slide releasably in acorresponding guide aperture 807. A system may include any desired orrequired number of guide pins and corresponding guide apertures (e.g.,from about 1 pair to about 20 pairs). According to some embodiments, allguide pins may be arranged on one cuff and all guide apertures may belocated on a facing cuff In some embodiments, a mixture of guide pinsand apertures may be arranged on one cuff with the corresponding guidepins and apertures arranged on the other cuff.

FIG. 8B illustrates the example load redistribution system 800 of FIG.8A from a different perspective and also illustrates an example of thefoot in the sling 801. As discussed previously, the sling 801 may beused to support and/or immobilize a subject's foot in a desired positionwithout permitting the foot to bear weight. For example, the sling maybe used to immobilize the foot in a position that prevents and/orminimizes an Achilles tendon contracture. The sling 801 may attach(e.g., by a slide, spring or adjustable canvas component (e.g., a strap)to avoid permitting the foot to bear weight) to at least one cuff 802and/or at least one strut 803. In the instance where canvas strap 808 orother similar material is used for attachment, the length of strap 808may be adjusted using a buckle 804 or any other means known in the artincluding snaps, clasps and the like. This permits one to adjust theheight of the sling and position the foot in the desired configurationwith the desired tension. The portion of the sling 801 in contact withthe foot may be of any useful material including, but not limited to,synthetic fabrics, plastics, foams, and natural products like cotton orwool. For example, polyurethane, polyethylene, neoprene, ethylene vinylacetate, silicone, rubber, and combinations thereof may be used.Alignment or guide pins 805 may be included to guide cuff componentsinto proper alignment with each other and to provide further support forthe device when it is surrounding the circumference of at least aportion of the subject's leg. For example, a system comprising two cuffsconfigured to contact each other along at least one edge 806, mayinclude one or more guide pins 805 (e.g., positioned generallyperpendicular to the at least one edge) on one cuff and correspondingguide apertures 807 (e.g., sleeves) on the other cuff In someembodiments, a guide pin 805 may slide releasably in a correspondingguide aperture 807. A system, in some embodiments, may include a guidepin/guide aperture system, a sling system, or both a guide pin/guideaperture system and a sling system.

A lower extremity brace may comprise, according to some embodiments, aprosthetic appliance. For example, a lower extremity brace configured tobe worn by an amputee, may comprise a portion of the missing appendage.In some embodiments, a lower extremity brace may comprise a strut (e.g.,an S-curve strut) having a proximal and a distal end, a cuff attached tothe proximal portion of the strut, and a prosthetic appliance (e.g., anartificial foot) attached to the distal end of the strut. In someembodiments, a cuff may be slidably attached to a strut to permitadnustment (e.g., adjustment based on the height of the wearer and/orthe length of the residual extremity). An amputee may wear a lowerextremity brace in such a way that weight is distributed away from themissing portion of the extremity to a portion of the extremity thatremains intact or substantially intact.

As will be understood by those skilled in the art who have the benefitof the instant disclosure, other equivalent or alternative compositions,devices, methods, and systems for redistributing a load can beenvisioned without departing from the description contained herein.Accordingly, the manner of carrying out the disclosure as shown anddescribed is to be construed as illustrative only.

Persons skilled in the art may make various changes in the shape, size,number, and/or arrangement of parts without departing from the scope ofthe instant disclosure. For example, the position and number of struts,pads, collars, and/or cuffs may be varied. In some embodiments, pads,pad shells, collars, and/or cuffs may be interchangeable.Interchangeability may allow the pressure exerted on a lateral surfaceof a subject's leg to be custom adjusted (e.g., by substituting largeror smaller pads). In addition, the size of a device and/or system may bescaled up (e.g., to be used for adult subjects) or down (e.g., to beused for juvenile subjects) to suit the needs and/or desires of apractitioner. Also, where ranges have been provided, the disclosedendpoints may be treated as exact and/or approximations as desired ordemanded by the particular embodiment. In addition, it may be desirablein some embodiments to mix and match range endpoints. All or a portionof a device and/or system for redistributing a load may be configuredand arranged to be disposable, serviceable, interchangeable, and/orreplaceable. These equivalents and alternatives along with obviouschanges and modifications are intended to be included within the scopeof the present disclosure. Accordingly, the foregoing disclosure isintended to be illustrative, but not limiting, of the scope of thedisclosure as illustrated by the following claims.

1. A method for facilitating ambulation of a subject having a leg withan impaired lower extremity, the method comprising: suspending at leasta portion of the impaired lower extremity in a non-weight bearingposition using a load redistribution system; and redistributing theweight to one or more unimpaired regions of the leg using the loadredistribution system, the load redistribution system comprising: aplatform; at least one vertical support fixed to the platform andextending upwardly from the platform; and at least one cuff mounted tothe at least one strut at a position sufficient to suspend the at leasta portion of the impaired lower extremity in a non-weight-bearingposition above the platform during ambulation, wherein the platform, theat least one strut, and the at least one cuff are configured to (a) bearat least the subject's full weight and (b) distribute the weight born toat least a portion of the subject's leg other than the subject's foot,and wherein components of the at least one cuff are releasably connectedin proper alignment using alignment pins, wherein the impaired lowerextremity comprises an amputation residual limb.
 2. A method forfacilitating ambulation of a subject according to claim 1, wherein theat least one vertical support comprises a strut positioned relative tothe subject's leg on which the system is worn opposite the subject'ssagittal plane or opposite the subject's coronal plane.
 3. A method forfacilitating ambulation of a subject according to claim 1, wherein theat least one vertical support comprises a strut positioned generallybehind the subject's leg on which the system is worn.
 4. A method forfacilitating ambulation of a subject according to claim 1, wherein thestrut has an S-curve profile.
 5. A method for facilitating ambulation ofa subject according to claim 1, wherein the at least one verticalsupport comprises a strut positioned generally outside the subject's legon which the system is worn
 6. A method for facilitating ambulation of asubject according to claim 1, wherein the at least one vertical supportextends distal to the subject's foot.
 7. A method for facilitatingambulation of a subject according to claim 1, wherein the at least onecuff comprises an anterior shell, an opposing posterior shell, and atleast one tension adjustment fastener configured to releasably connectthe anterior shell and the posterior shell, wherein the anterior shelland the posterior shell are configured to combine to surround thecircumference of the subject's leg.
 8. A method for facilitatingambulation of a subject according to claim 7, wherein the anterior shellcomprises at least one fastener guide positioned across the anteriorsurface of the anterior shell and configured to receive at least aportion of the at least one tension adjustment fastener.
 9. A method forfacilitating ambulation of a subject according to claim 7, wherein theanterior shell and/or the posterior shell comprise a moldable plasticselected from the group consisting of a thermoplastic, a thermosettingplastic, and combinations thereof
 10. A method for facilitatingambulation of a subject according to claim 7, wherein the anterior shellor the posterior shell is adjustably mounted to the at least onevertical support.
 11. A method for facilitating ambulation of a subjectaccording to claim 7, wherein the at least one cuff further comprises atleast one pad fixed to the anterior shell and at least one pad fixed tothe posterior shell.
 12. A method for facilitating ambulation of asubject according to claim 11, wherein the pads independently comprise amaterial selected from the group consisting of polyurethane,polyethylene, neoprene, ethylene vinyl acetate, foam, silicone, rubber,and combinations thereof.
 13. A method for facilitating ambulation of asubject according to claim 7, wherein the at least one cuff furthercomprises at least one bladder fixed to the anterior shell and at leastone bladder fixed to the posterior shell.
 14. A method for facilitatingambulation of a subject according to claim 13, wherein at least one ofthe bladders is at least partially filled with a fill material.
 15. Amethod for facilitating ambulation of a subject according to claim 14,wherein the fill material comprises a foam.
 16. A method forfacilitating ambulation of a subject according to claim 1, whereinredistributing the weight to one or more unimpaired regions of the legcomprises redistributing the weight to one or more lateral surfaces ofthe leg.
 17. A method for facilitating ambulation of a subject accordingto claim 16, wherein redistributing the weight to one or more lateralsurfaces of the leg further comprises adjusting the pressure applied toat least one lateral surface.
 18. A method for facilitating ambulationof a subject having a leg with an impaired lower extremity, the methodcomprising: contacting the leg with a load redistribution system tosuspend at least the impaired lower extremity in a non-weight bearingposition; and redistributing at least the weight of the subject duringambulation to one or more unimpaired regions of the leg, the loadredistribution system comprising: a platform; at least one verticalsupport fixed to the platform and extending upwardly from the platform;and at least one cuff adjustably mounted to the at least one strut at aposition sufficient to suspend the at least a portion of the impairedlower extremity in a non-weight-bearing position above the platformduring ambulation, wherein the platform, the at least one strut, and theat least one cuff are configured to (a) bear at least the subject's fullweight and (b) distribute the weight born to at least a portion of thesubject's leg other than the subject's foot wherein the at least onecuff comprises at least one collar having opposite ends spaced apart anda tension adjustment fastener corresponding to each collar, each tensionadjustment fastener configured to releasably connect the opposing endsof the corresponding collar, wherein each collar and correspondingtension adjustment fastener are together configured to surround thecircumference of the subject's leg, wherein the impaired lower extremitycomprises an amputation residual limb.
 19. A method for facilitatingambulation of a subject according to claim 18, wherein the at least onevertical support comprises a single vertical support.
 20. A method forfacilitating ambulation of a subject according to claim 19, wherein thesingle vertical support is sized to extend distal to the subject's foot.